Status:

RECRUITING

A Study of Navenibart in Participants With Hereditary Angioedema

Lead Sponsor:

Astria Therapeutics, Inc.

Conditions:

Hereditary Angioedema (HAE)

Eligibility:

All Genders

12+ years

Phase:

PHASE3

Brief Summary

This is a Phase 3 multicenter, randomized, double-blind, placebo-controlled clinical trial evaluating the safety and efficacy of subcutaneous administration of navenibart in adult and adolescent parti...

Eligibility Criteria

Inclusion Criteria:

  • Documented diagnosis of HAE (Type 1 or 2). The following must be met:

    1. Documented clinical history consistent with HAE
    2. Lab findings consistent with HAE Type 1 or 2
  • Experienced at least 2 HAE attacks during the Run-In period, as confirmed by an investigator based on meeting the protocol-specified definition of an HAE attack.

Exclusion Criteria:

  • Any concomitant diagnosis of another form of chronic angioedema, such as acquired C1 inhibitor deficiency, HAE with normal C1-INH (also known as HAE type 3), idiopathic angioedema, or angioedema associated with urticaria.

  • Use of therapies prescribed for the prevention of HAE attacks may not be used during the trial or within the below time frames prior to the Run-In Period (adult participants may be on these medications at the time of the Screening Visit, but will need to washout prior to entering the Run-In Period).

    1. Tranexamic acid, oral danazol, oral stanazolol, and oral oxandrolone within 3 days prior to Run-In
    2. Plasma-derived C1INH for LTP within 14 days prior to Run-In
    3. Berotralstat within 21 days prior to Run-In
    4. Lanadelumab within 70 days prior to Run-In
    5. Garadacimab within 90 days prior to Run-In

Key Trial Info

Start Date :

March 20 2025

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

September 1 2027

Estimated Enrollment :

145 Patients enrolled

Trial Details

Trial ID

NCT06842823

Start Date

March 20 2025

End Date

September 1 2027

Last Update

April 9 2026

Active Locations (85)

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Page 1 of 22 (85 locations)

1

Site 9

Birmingham, Alabama, United States, 35209

2

Site 2

Scottsdale, Arizona, United States, 85251

3

Site 3

Little Rock, Arkansas, United States, 72205

4

Site 26

San Diego, California, United States, 92122

A Study of Navenibart in Participants With Hereditary Angioedema | DecenTrialz